Preliminary analysis of an expanded access study of the fixed-dose combination of pertuzumab (P) and trastuzumab (H) for subcutaneous injection (PH FDC SC) for athome administration (admin) in patients (pts) with HER2-positive (HER2+) breast cancer (BC) during the COVID-19 pandemic
Journal of Clinical Oncology
; 40(16), 2022.
Article
in English
| EMBASE | ID: covidwho-2009520
ABSTRACT
Background:
Standard of care for HER2+ early/first-line metastatic BC (EBC/MBC) is P + H and concurrent chemotherapy (CT);PH FDC SC offers faster, more convenient admin vs intravenous (IV) P + H. COVID-19 has caused unprecedented strain on healthcare systems and disruption to cancer care;treatment (Tx) at home may enable pts to continue cancer Tx;reduce exposure to COVID-19;free up hospital resources. This study's mainobjectives:
to enable continuity of care during COVID-19;to assess safety of PH FDC SC given at home.Methods:
This is an ongoing single-arm, hybrid, decentralized clinical trial (NCT04395508). Pts with HER2+ EBC/MBC who completed concurrent CT with P + H IV and are receiving/about to receive maintenance P + H IV, PH FDC SC, or H SC are switched to PH FDC SC given at home by a home health nursing provider (HHNP) until disease progression, unacceptable toxicity, pt withdrawal, or physician recommendation (pts with EBC will complete ≤18 cycles). The study endpoint is safety. A subset of pts took part in HARRIET, a substudy of at-home cardiac surveillance with artificial intelligence-guided cardiac ultrasound and optional 6L ECG acquired by an HHNP.Results:
Data for 114 pts (1 male) were available at cutoff (Jan 19, 2022) 18 (16%) completed Tx;20 (18%) discontinued;76 (67%) remain on study;79 (69%) had a COVID-19 vaccine while on study. Median age was 49 years;pts were balanced between EBC (n = 55, 48%) and MBC (n = 59, 52%);received a median of 6 (EBC) and 8 (MBC) cycles;and were from metropolitan (n = 109), urban (n = 4), and rural (n = 1) areas. 11 pts tested COVID-19-positive during the Tx phase 8 continued Tx after appropriate COVID-19 Tx and/or quarantine. Safety is summarized in the table. No new adverse events (AEs) emerged due to home admin. AEs of special interest were grade (gr) 1-2 admin-related reactions (n = 76, 67%), hypersensitivity (n = 5, 4%), cardiac dysfunction (n = 4, 4%), except 1 case of gr ≥3 diarrhea. AEs leading to study Tx discontinuation or interruption/dose reduction occurred in 3 (3%) and 15 (13%) pts. A subset of 7 pts completed at-home cardiac surveillance testing;quantitative assessment of left ventricular ejection fraction was feasible in 3 (43%);5 (71%) preferred at-home surveillance to clinic.Conclusions:
In this preliminary analysis, safety of PH FDC SC at home was consistent with the established P + H safety profile, indicating that PH FDC SC at home is a viable option for continuing BC care during and beyond COVID-19.
endogenous compound; epidermal growth factor receptor 2; pertuzumab; SARS-CoV-2 vaccine; trastuzumab; adult; adverse drug reaction; artificial intelligence; cancer chemotherapy; cancer combination chemotherapy; cancer patient; clinical trial; compassionate use; conference abstract; controlled study; coronavirus disease 2019; diarrhea; drug combination; drug safety; drug therapy; drug withdrawal; electrocardiogram; electrocardiography; female; heart disease; heart left ventricle ejection fraction; home care; human; human epidermal growth factor receptor 2 positive breast cancer; hypersensitivity; intravenous drug administration; major clinical study; male; middle aged; pandemic; patient care; pH; physician; quantitative analysis; quarantine; side effect; ultrasound
Full text:
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Collection:
Databases of international organizations
Database:
EMBASE
Language:
English
Journal:
Journal of Clinical Oncology
Year:
2022
Document Type:
Article
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